Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).

Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).

Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

metformin (stable dose for 6 weeks)

pioglitazone (stable dose for 6 weeks)

a combination of metformin and pioglitazone (stable dose for 6 weeks)

Have HbA1C between 7.1% and 10.5%, inclusive.

Have a body mass index (BMI) ≤45 kg/m2.

Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.

Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.

Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.

Women who are breastfeeding.

Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.

Have had a kidney transplant or are currently on kidney dialysis.

Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.

Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.

Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.

Are currently on a weight-loss program or have been on one within 3 months of entering the study.

Have had a blood transfusion or severe blood loss within 3 months of entering the study.

Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.

Have an irregular sleep cycle (for example, sleeping during the day and working during the night).

Have a history of pancreatitis.

Have received treatment with an experimental drug within 30 days of entering the study.

If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.

If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.

If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765817